BD PhaSeal Optima 515064Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 00382905150647), received between Oct 17, 2018 and Jul 31, 2026 — classified as 1 injury, 72 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (39 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 16, 2025Open, Classified

   Closed system drug transfer devices were shipped to the U.S. market without a U.S. version of the instructions for use, which could be an issue if a healthcare professional is prompted to review it.

   Z-2453-2025 · Root cause: Error in labeling · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 73 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2026Infusion or Flow Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50103800 ↗
• MalfunctionFeb 25, 2026Contamination

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24449851 ↗
• MalfunctionFeb 24, 2026Contamination

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24437229 ↗
• MalfunctionFeb 2, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE BD PROTECTOR P20-O HAD A DISCONNECTION OR BROKEN / LOOSE CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE RECEIVED INITIAL NOTIFICATION VIA EMAIL ONLY. DETAILED INFORMATION WILL BE AVAILABLE ON JANUARY 19TH. SINCE THE PRODUCT RECALL WILL ALSO TAKE PLACE ON JANUARY 19TH, IT WILL TAKE MORE THAN A WEEK FROM THE INITIAL REPORT TO THE SHIPMENT OF THE REPLACEMENT PRODUCT. ADDITIONAL INFORMATION 1ST ITEM. USING AN ASSEMBLY FIXTURE, I TRIED TO ATTACH A PROTECTOR 515064 TO A CARBOPLATIN VIAL. IN THAT STATE, WHEN I OPERATED THE HANDLE OF THE ASSEMBLY FIXTURE, THE PROTECTOR VENTILATION NEEDLE BROKE. (IN PARTICULAR, IT WAS CONFIRMED THAT THERE WAS NO FEELING OF THE PROTECTOR'S VENTILATION NEEDLE GETTING CAUGHT IN THE ALUMINUM CAP OF THE VIAL.) THE VENTILATION NEEDLE DOES NOT PENETRATE THE RUBBER STOPPER OF THE VIAL, SO THERE IS NO CONTAMINATION OF CARBOPLATIN (ANTICANCER DRUG). 2ND ITEM. USING AN ASSEMBLY FIXTURE, I TRIED TO ATTACH A PROTECTOR 515064 TO A CARBOPLATIN VIAL. WHEN THE PROTECTOR'S CLAW TOUCHED THE ALUMINUM CAP OF THE VIAL, THE PROTECTOR'S CLAW WAS DAMAGED. (THE PROTECTOR'S NAIL WAS DAMAGED BEFORE THE PROTECTOR'S VENTILATION NE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24242231 ↗
• MalfunctionFeb 2, 2026Nonstandard Device

  IT WAS REPORTED THAT THE BD PROTECTOR P20-O HAD A BROKEN SPIKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE RECEIVED INITIAL NOTIFICATION VIA EMAIL ONLY. DETAILED INFORMATION WILL BE AVAILABLE ON (B)(6). SINCE THE PRODUCT RECALL WILL ALSO TAKE PLACE ON (B)(6), IT WILL TAKE MORE THAN A WEEK FROM THE INITIAL REPORT TO THE SHIPMENT OF THE REPLACEMENT PRODUCT. ADDITIONAL INFORMATION - 1ST ITEM: USING AN ASSEMBLY FIXTURE, I TRIED TO ATTACH A PROTECTOR 515064 TO A CARBOPLATIN VIAL. IN THAT STATE, WHEN I OPERATED THE HANDLE OF THE ASSEMBLY FIXTURE, THE PROTECTOR VENTILATION NEEDLE BROKE. (IN PARTICULAR, IT WAS CONFIRMED THAT THERE WAS NO FEELING OF THE PROTECTOR'S VENTILATION NEEDLE GETTING CAUGHT IN THE ALUMINUM CAP OF THE VIAL.) THE VENTILATION NEEDLE DOES NOT PENETRATE THE RUBBER STOPPER OF THE VIAL, SO THERE IS NO CONTAMINATION OF CARBOPLATIN (ANTICANCER DRUG). 2ND ITEM: USING AN ASSEMBLY FIXTURE, I TRIED TO ATTACH A PROTECTOR 515064 TO A CARBOPLATIN VIAL. WHEN THE PROTECTOR'S CLAW TOUCHED THE ALUMINUM CAP OF THE VIAL, THE PROTECTOR'S CLAW WAS DAMAGED. (THE PROTECTOR'S NAIL WAS DAMAGED BEFORE THE PROTECTOR'S VENTILATION NEEDLE STUCK INTO THE VIAL'S RUBBER STOPPE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24242228 ↗
• MalfunctionJan 29, 2026Leak/Splash

  IT WAS REPORTED THAT THE BD PROTECTOR P20-O HAD LEAKAGE THROUGH THE PHASEAL MEMBRANE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE LEAKAGE OBSERVED DURING INTERNAL TESTS. FOR A TENDER SUBMISSION SAMPLES WERE PROVIDED AND WERE TESTED IN ACCORDANCE WITH A INTERNAL METHODOLOGY WHERE VERIFICATION WAS DONE OF LEAK FREE TRANSFER USING LITMUS PAPER. THE RESULTS WERE ASSESSED BLINDLY BY THREE HOSPITAL PHARMACISTS, INDEPENDENTLY OF ONE ANOTHER. 22 SAMPLING POINTS WERE EVALUATED AS POSITIVE, SO LEAKAGE WAS DETECTED. ALL PHASEAL OPTIMA PRODUCTS WERE TESTED AND BELOW YOU CAN FIND THE SKU NUMBERS WITH LOT NUMBERS THAT THE SITE RECEIVED: 515060. 2504409. 515064. 2505405. 515064. 2507401. 515070. 2502502. 515070. 2507501. 515052. 2505303. 515078. 2504506. WHEN DID THE INCIDENT OCCUR? - AFTER USE. DETAILED DESCRIPTION: TWO SETS OF TEN TESTS BY THREE PREPARERS. THE WELL-KNOWN FLUORESCENCE TEST DESCRIBED IN THE TENDER WAS USED. THE LIMIT WAS 4 POSITIVE POINTS. BD HAD STAINING ON THE TEST SHEETS 22 TIMES. THE TEST WAS PERFORMED ON THE MEMBRANES OF THE INJECTOR, PROTECTOR, AND CONNECTOR, ESPECIALLY AFTER DRAWING AND INJECTING MULTIPLE TIMES. I ASKED FOR A DE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24218241 ↗
• MalfunctionJan 29, 2026Leak/Splash

  IT WAS REPORTED THAT THE BD PROTECTOR P20-O HAD LEAKAGE THROUGH THE PHASEAL MEMBRANE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE LEAKAGE OBSERVED DURING INTERNAL TESTS. FOR A TENDER SUBMISSION SAMPLES WERE PROVIDED AND WERE TESTED IN ACCORDANCE WITH AN INTERNAL METHODOLOGY WHERE VERIFICATION WAS DONE OF LEAK FREE TRANSFER USING LITMUS PAPER. THE RESULTS WERE ASSESSED BLINDLY BY THREE HOSPITAL PHARMACISTS, INDEPENDENTLY OF ONE ANOTHER. 22 SAMPLING POINTS WERE EVALUATED AS POSITIVE, SO LEAKAGE WAS DETECTED. ALL PHASEAL OPTIMA PRODUCTS WERE TESTED AND BELOW YOU CAN FIND THE SKU NUMBERS WITH LOT NUMBERS THAT THE SITE RECEIVED: 515060, 2504409, 515064, 2505405, 515064, 2507401, 515070, 2502502, 515070, 2507501, 515052, 2505303, 515078, 2504506. WHEN DID THE INCIDENT OCCUR? AFTER USE. DETAILED DESCRIPTION: TWO SETS OF TEN TESTS BY THREE PREPARERS. THE WELL-KNOWN FLUORESCENCE TEST DESCRIBED IN THE TENDER WAS USED. THE LIMIT WAS 4 POSITIVE POINTS. BD HAD STAINING ON THE TEST SHEETS 22 TIMES. THE TEST WAS PERFORMED ON THE MEMBRANES OF THE INJECTOR, PROTECTOR, AND CONNECTOR, ESPECIALLY AFTER DRAWING AND INJECTING MULTIPLE TIMES. I ASKED FOR A DES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24218240 ↗
• MalfunctionAug 26, 2025Leak/Splash; Leak/Splash

  IT IS REPORTED LEAKAGE. EVENT DESCRIPTION: MY TEAM HAVE NOTICED AN ISSUE WITH THE OPTIMA. WE HAVE BEEN SEEING "LEAKAGE". WE HAVE NOTICED A COLOURED SPOT ON THE TIP OF THE P20-O AFTER WE REMOVE A DOSE. THIS MORE NOTICEABLE ON THE COLOURED CHEMOTHERAPY (EG DOXORUBICIN).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22896784 ↗
• MalfunctionJul 7, 2025Nonstandard Device; Defective Component; Nonstandard Device; Defective Component

  DESCRIPTION: IT IS REPORTED, CORING. EVENT DETAILS: WE HAVE NOTICED SOME SMALL PARTICULATES IN BAGS AFTER COMPOUNDING THAT LOOKS LIKE SMALL STRANDS OF CLEAR PLASTIC. AT FIRST, I THOUGHT IT WAS ISOLATED TO 2 BAGS OF NS 100 ML WITH KEYTRUDA, BUT WE FOUND ANOTHER PIECE IN A TRAZIMERA BAG IN NS 250 ML. WE HAVE ALSO HAD ISSUES WITH THE SPIKE ADAPTER CORING OUR TRAZIMERA VIALS. PLEASE CONFIRM WHEN THE PLASTICS WERE IDENTIFIED: ON VERIFICATION OF THE FINAL PRODUCT. THE BAGS WERE BOTH SPIKED WITH THE BD PHASEAL OPTIMA INFUSION ADAPTER (515078). ADDITIONAL INFORMATION: WHAT WERE THE DATES OF EVENTS? 6/24/2025. PLEASE CONFIRM WHEN THE PLASTICS WERE IDENTIFIED. (BEFORE OR DURING ADMINISTRATION). ON VERIFICATION OF THE FINAL PRODUCT. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. WE HAD TO REMAKE THE IV FOR THE PATIENT. PLEASE DESCRIBE WHERE YOU BELIEVE THE MICROPLASTICS TO BE ORIGINATING FROM. WE THINK THE PLASTIC MAY BE COMING FROM THE SECONDARY SET DUE TO THE PLASTICS BEING IN TWO 100ML BAGS AND A 250ML BAG. BOTH BAG SIZES HAD DIFFERENT DRUGS IN THEM AS WELL. PLEASE DETAIL THE SIZE OF THE VIAL NECK OF THE IMPACTED VIALS (13MM, 20M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412562 ↗
• MalfunctionJun 11, 2025Break; Break

  VERBATIM: MATERIAL # 515064, BATCH # 2502707. WE HAD A CSTD MALFUNCTION LAST NIGHT. THE PROTECTOR SPIKE CAME OUT OF THE DEVICE WHEN THE TECHNICIAN TRIED ATTACHING IT TO THE VIAL. ADDITIONAL INFORMATION: 1. COULD YOU PLEASE CONFIRM IF YOU ATTACH THE PROTECTOR MANUALLY OR USING THE ASSEMBLY FIXTURE? WHAT MEDICATION WAS BEING USED DURING THIS INCIDENT? WE ATTACH MANUALLY. THE DRUG WAS VALPROIC ACID. 2. DID LEAK OCCURRED? NO. 3. WAS THERE ANY HARM TO THE PATIENT/CAREGIVER? (DETAIL) NO HARM.

  Patient problems: Chemical Exposure

  MAUDE report 22183144 ↗
• MalfunctionJun 9, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22167506 ↗
• MalfunctionMay 21, 2025Defective Component; Defective Component

  DESCRIPTION: IT WAS REPORTED BY CUSTOMER THAT WHEN MAKING A MITOMYCIN DOSE THE DRUG COULD NOT BE RECONSTITUTED AFTER APPLYING THE PROTECTOR. THE SOFT RUBBER SHEATH COVERING THE SPIKE SEEMED TO BECOME STUCK PART WAY. VERBATIM: MATERIAL#: 515064 BATCH#: UNKNOWN AT CEN YESTERDAY, WHEN MAKING A MITOMYCIN DOSE THE DRUG COULD NOT BE RECONSTITUTED AFTER APPLYING THE PROTECTOR. THE SOFT RUBBER SHEATH COVERING THE SPIKE SEEMED TO BECOME STUCK PART WAY. WE DIDN'T HAVE ANOTHER VIAL OF DRUG SO WE REMOVED THE PROTECTOR AND APPLIED A NEW ONE. THE DEFECTIVE ONE WAS SAVED. WE HAVE 2 LOT NUMBER AND ARE NOT CERTAIN WHICH ONE WAS USED AS THE PACKAGING WAS DISCARDED: 2411403, 2409405

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22059451 ↗
• MalfunctionApr 28, 2025Leak/Splash; Leak/Splash

  RECORD OPENED IN RELATION TO EXISTING RECORD. DURING FOLLOW UP AN ADDITIONAL EVENT OCCURRED. INITIAL VERBATIM "WHEN I DISCONNECT THE N35 - INJECTOR, FROM THE P20 PROTECTOR THERE IS A DROPLET ON THE MEMBRANE OF THE P20. I HAVE WIPE THE MEMBRANE WITH AN ALCOHOL WIPE THERE IS A DROP ON THE WIPE - IT IS ESPECIALLY NOTICEABLE WHEN COMPOUNDING DOXORUBICIN. THIS HAPPENS EVERY TIME WE COMPOUND WITH DOX, AND POSSIBLY WITH OTHER DRUGS BUT YOU CAN'T SEE WHEN IT'S NOT RED" PER RESPONSE (B)(6) 2025: I HAVE A PICTURE ADDED OF THE BOX W/ LOT NUMBER I WILL JUST USE TODAY AS THE DATE (B)(6) 2025 SINCE I TOOK THE PICTURES TODAY. I HAVE A PICTURE ADDED OF THE BOX W/ LOT NUMBER THERE IS NOT A NEGATIVE PATIENT OUTCOME ASSOCIATED WITH THESE INCIDENTS BUT AFFECT PHARMACIST AND PHARMACY TECHNICIANS WHO ARE IN DAILY CONTACT WITH THIS DRUG. THEY ARE BEING EXPOSED TO THE DRUG, SMALL THAT IT IS, WHICH DEFEATS THE PURPOSE OF HAVING PHASEAL. I HAVE ATTACHED PHOTOS OF THE VIAL I USED TODAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21918548 ↗
• MalfunctionApr 23, 2025Leak/Splash; Leak/Splash

  MATERIAL#: 515064 BATCH#: 2501416 IT WAS REPORTED BY CUSTOMER THAT WHEN THEY DISCONNECT THE N35 - INJECTOR, FROM THE P20 PROTECTOR THERE IS A DROPLET ON THE MEMBRANE OF THE P20.THEY HAVE WIPED THE MEMBRANE WITH AN ALCOHOL WIPE THERE IS A DROP ON THE WIPE - IT IS ESPECIALLY NOTICEABLE WHEN COMPOUNDING DOXORUBICIN. THIS HAPPENS EVERY TIME WE COMPOUND WITH DOX, AND POSSIBLY WITH OTHER DRUGS BUT YOU CAN'T SEE WHEN IT'S NOT RED" VERBATIM: "WHEN I DISCONNECT THE N35 - INJECTOR, FROM THE P20 PROTECTOR THERE IS A DROPLET ON THE MEMBRANE OF THE P20. I HAVE WIPE THE MEMBRANE WITH AN ALCOHOL WIPE THERE IS A DROP ON THE WIPE - IT IS ESPECIALLY NOTICEABLE WHEN COMPOUNDING DOXORUBICIN. THIS HAPPENS EVERY TIME WE COMPOUND WITH DOX, AND POSSIBLY WITH OTHER DRUGS BUT YOU CAN'T SEE WHEN IT'S NOT RED" ADDITIONAL INFORMATION I WILL JUST USE TODAY AS THE DATE 4/18/25 SINCE I TOOK THE PICTURES TODAY. I HAVE A PICTURE ADDED OF THE BOX W/ LOT NUMBER - 2501416 THERE IS NOT A NEGATIVE PATIENT OUTCOME ASSOCIATED WITH THESE INCIDENTS BUT AFFECT PHARMACIST AND PHARMCY TECHNICIANS WHO ARE IN DAILY CONTACT WITH THIS DRUG. THEY ARE BEING EXPOSED TO THE DRUG, SMALL THAT IT IS, WHICH DEFEATS THE PURPOSE OF HAVING P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21891790 ↗
• MalfunctionJan 21, 2025Leak/Splash; Leak/Splash

  MATERIAL# 515064 BATCH# 2405403 AND 2406413. P-20 PROTECTORS (515064) ARE LEAKING RESIDUE ON THE MEMBRANE CONSISTENTLY. ADDITIONAL INFORMATION: DURING THE DETACHMENT OF THE BD OPTIMA INJECTOR (N40 AND/OR N-35) FROM THE VIAL COMPONENTS (BD OPTIMA PROTECTOR P-20 OR BD OPTIMA INFUSION ADAPTER C100-O), WE CONSISTENTLY NOTICE VISIBLE DRUG RESIDUE LEFT ON THE TOP OF THE VIAL ADAPTER. THERE HAS BEEN NO PATIENT HARM OR INJURY. WE ARE JUST CONCERNED FOR OUR TEAM MEMBERS WHO ARE BEING EXPOSED TO HAZARDOUS DRUG RESIDUE DURING PREPARATION OF THESE MEDICATIONS. IT APPEARS THAT LIQUID IS COMING OUT OF THE MEMBRANE. THIS IS ALSO OCCURRING AFTER THE FIRST WITHDRAWAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21196863 ↗
• MalfunctionJan 15, 2025Contamination; Contamination

  MATERIAL # 515064. BATCH # 2409403. VERBATIM: PARTICLES FOUND IN THE VIAL AFTER USE OF OUR OPTIMA # 515064 AND 515052. ¿ WHAT WAS THE OUTCOME RE: PATIENT - REMADE THE DRUG WITHOUT PHASEAL AND NO ISSUE ¿ ARE THERE ANY ADVERSE EVENTS/SERIOUS INJURIES? NO ¿ WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? YES, WE REMADE THE PRODUCT TWICE UTILIZI. ¿ THE DATE THIS HAPPENED? (B)(6)2025. ¿ WHILE BEING USED ON A PATIENT? DID NOT USE ON PATIENT, REMADE THE PRODUCT WITHOUT CSTD AND NO ISSUE. ¿ WHAT OCCURRED: AFTER RECONSTITUTION OUR TECHNICIAN NOTICED A PARTICULATE IN THE SOLUTION AFTER IT WAS DRAWN INTO A SYRINGE. ¿ WHAT TYPE OF PROCEDURE, COMPOUNDING: THIS OCCURED AND WAS NOTICED DURING COMPOUNDING. ¿ PRODUCT: DO YOU HAVE THE AFFECTED TWO ITEMS THAT THAT YOU REFERENCED BELOW? 515064 GREEN TOP PROTECTOR & 515052 INJECTOR- YES, WE STILL HAVE THE ITEMS. WE PLAN TO KEEP THEM UNTIL THE SPONSOR OF THE STUDY HAS FINISHED INVESTIGATING AND APPROVED DESTRUCTION OF THE DRUG. ¿ LOT # CAN YOU PLEASE PROVIDE? AND WOULD YOU HAPPEN TO HAVE THE PACKAGING AS WELL? OR CAN YOU TAKE A PICTURE THE REPRESENTATIVE LOT # FROM THE PARS? REF (B)(4) LOT#2409403, REF# (B)(4) LOT# 2407301

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21162227 ↗
• MalfunctionDec 4, 2024Leak/Splash; Leak/Splash

  VERBATIM: TODAY I ALSO HAD A LEAK WITH A VIAL OF MVASI THAT WAS SPIKED YESTERDAY. THE LIQUID SIMPLY RAN OUT THROUGH THE ¿SPIKE HOLE¿. USED THE BOTTLE OF MVASI ( MONOCLONAL ANTI BODY) THE FIRST TIME THE DAY BEFORE WITH PROTECTOR. AFTERWARDS STORE IT IN THE REFRIGERATOR AND WANT TO USE IT AGAIN THE NEXT DAY AND THEN THE LIQUID RUN OUT BETWEEN THE VIAL AND THE PROTECTOR WHEN DID THE INCIDENT OCCUR? DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20844194 ↗
• MalfunctionSep 19, 2024Leak/Splash; Leak/Splash

  MATERIAL# 515064. BATCH# 2404403. IT WAS REPORTED BY CUSTOMER THAT THE DRUG BEING USED DOXORUBICIN IS COMING UP AT THE TOP VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED PRODUCTCOMPLAINT - CUSTOMER CALLED TO REPORT THAT WHILE USING THE PHASEAL PRODUCT: REF (B)(4), LOT 2404403, THE DRUG BEING USED DOXORUBICIN IS COMING UP AT THE TOP. SAMPLE DISCARDED, NO EXPOSURE OR INJURY TO PT AND HEALTH CARE PROFESSIONAL. PICTURE SAMPLES AVAILABLE. DOE (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20258341 ↗
• MalfunctionApr 29, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  MATERIAL#: 515064, BATCH NUMBER#: 2309405. IT WAS REPORTED BY CUSTOMER THAT BLACK SPOTTING ON END OF P20-O VIAL SPIKE BY RUBBER COVER- THIS IS URGENT, THIS IS THE SECOND LOT NUMBER, THE ACCOUNT IS THINKING OF GOING BACK TO USING NEEDLE AND SYRINGE, THEY ARE WORRIED THAT THIS IS MOLD. THE PROTECTOR WAS NOT USED, AS THE TECH NOTICED THE SPOTTING UPON OPENING THE PACKAGING AND TAKING THE GREEN CAP OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19200966 ↗
• MalfunctionApr 29, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  MATERIAL #515064 . LOT # 2308404. IT WAS REPORTED BY CUSTOMER THAT THEY NOTICED SOME BLACK LIKE RESIDUE ALL ALONG THE INNER SILICONE THAT COVERS THE SPIKE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED TODAY WHILE I WAS COMPOUNDING, WHEN I REMOVED THE GREEN CAP FROM THE P20 PROTECTOR REF515064 I NOTICED SOME BLACK LIKE RESIDUE ALL ALONG THE INNER SILICONE THAT COVERS THE SPIKE. 26-APR: FU SENT. CUSTOMER RESPONSE ON APRIL 26, 2024. "THE PRODUCT WAS NOT USED AS THE TECHNICIAN NOTICED THIS AFTER UNPACKING AND TAKING OFF THE CAP AND GETTING READY TO SPIKE THE VIAL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19200754 ↗
• MalfunctionMar 13, 2024Leak/Splash; Leak/Splash

  MATERIAL: 515064 BATCH: UNKNOWN IT WAS REPORTED BY THE CUSTOMER THAT PHASAL OPTIMA SAMPLES HAVE BEEN LEAKING. I HAVE ADDITIONAL PHASEAL OPTIMA SAMPLES THAT HAVE BEEN LEAKING FROM PARKLAND HEALTH. CAN SOMEONE PLEASE PROVIDE A SHIPPING LABEL TO THE APPROPRIATE DESTINATION TO FURTHER INVESTIGATE? RESPONSE FROM BD REP ON (B)(6)2024. IT¿S AN ONGOING ISSUE ALMOST DAILY AT PARKLAND. THEIR DEVICES ARE LEAKING AT RANDOM, SOMETIMES FROM THE SAME LOT NUMBER, EVEN WITH FIRST USE AND USED PER IFU. I BECAME AWARE OF THE INITIAL LEAKAGE ON (B)(6) AND SUBMITTED A PIR. IT HAPPENED ON SEVERAL DEVICES WHEN I WENT IN FOR STAGED OBSERVATIONS, THOSE WERE THE SAMPLES I PREVIOUSLY SHIPPED. I ASKED THE CONTACT TO BAG ADDITIONAL LEAKING PROTECTORS AND INJECTORS FOR ADDITIONAL SAMPLES TO BE SHARED WITH THE PLATFORM. WHAT DATE DID YOU BECOME AWARE OF THESE INCIDENTS? ¿ ORIGINALLY ON (B)(6) , HAS HAPPENED DAILY SINCE THEN ARE YOU ABLE TO PROVIDE THE MATERIAL NUMBER FOR THESE PHASEAL¿S? 515064, 515052 ARE YOU ABLE TO PROVIDE THE LOT NUMBERS? NO CAN YOU PROVIDE THE NUMBER OF OCCURRENCES? 15+ CAN YOU PROVIDE AN EVENT DATE FOR EACH INCIDENT? EVERY DAY CAN YOU PROVIDE ADDITIONAL DETAILS REGARDING THE LEAKAGE? WHERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18895045 ↗
• MalfunctionMar 12, 2024Leak/Splash; Leak/Splash

  MATERIALS#: 515064, BATCH#: UNKNOWN. IT WAS REPORTED BY THE CUSTOMER THAT THE PRODUCT IS LEAKING AFTER THEY ATTACH THE PRODUCT TOGETHER. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. THE PRODUCT IS LEAKING AFTER THEY ATTACH THE PRODUCT TOGETHER. 515064, 515056, AND 515079. PER FOLLOW UP WITH REP: WE HAVE BEEN TO THIS CLINIC AND WORKED WITH THEM ON PROPER USE OF PHASEAL OPTIMA. THEY WERE NOT USING IT CORRECTLY SO IT IS NOT A PRODUCT ISSUE. OUR TEAM TRAINED THE STAFF ON PROPER USAGE MOVING FORWARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18884753 ↗
• MalfunctionFeb 29, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18806308 ↗
• MalfunctionDec 14, 2023Fracture; Fracture

  NO ADDITIONAL INFORMATION

  Patient problems: Insufficient Information

  MAUDE report 18329098 ↗
• MalfunctionNov 28, 2023Leak/Splash; Leak/Splash

  MATERIAL#: 515064 BATCH#: 2305403 IT WAS REPORTED BY CUSTOMER THAT I HAD MY COWORKER TAKE SOME IMAGES FOR ME SINCE I WAS COMPOUNDING. THEY ARE ATTACHED BELOW. WE HAD ANOTHER INCIDENT WHERE TWO DOXORUBICIN VIALS HAD THE DOXORUBICIN ON THE OUTSIDE OF THE SEPTUM FOR BOTH THE VIAL PROTECTOR AND THE INJECTOR AND I JUST WANTED TO FOLLOW UP WITH YOU ABOUT THIS. I KNOW I HAVE SENT THIS ONE IN THE PAST AND THE RESULTS WERE INDICATING AN SHADOW ON THE SEPTUM, SO WE TOOK SOME MORE ROBUST IMAGES THIS TIME WHERE YOU CAN SEE THE RED IS REMOVED ONTO A ALCOHOL WIPE AND NOT A SHADOW. THE VIALS WERE OUT OF THE FRIDGE FOR APPROX A HALF HOUR PRIOR TO USE. THE ONE VIAL WHICH LOOKS FULL WAS A NEW VIAL AND NEW PROTECTOR, WE WENT INTO THIS ONE TWICE, ONCE TO PUT AIR, AND THE OTHER TIME TO RE-ATTACH THE NEXT SYRINGE. I BELIEVE SHE TOOK A BETTER SMALL VIDEO SO I WILL ASK HER IF SHE CAN CHECK AND SEND IT ALONG AS WELL. PROTECTOR #(B)(4) THE LOT IS 2305403 EXP 2025-04-30. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. I HAD MY COWORKER TAKE SOME IMAGES FOR ME SINCE I WAS COMPOUNDING. THEY ARE ATTACHED BELOW. WE HAD ANOTHER INCIDENT WHERE TWO DOXORUBICIN VIALS HAD THE DOXORUBICIN ON THE OUTSI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18220505 ↗